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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K861423
Device Name DEMAND OXYGEN SAVER SYSTEM (D02S)
Applicant
Applied Membrane Technology, Inc.
11558 Encore Circle
Minnetonka,  MN  55343
Applicant Contact STEPHEN P CONOVER
Correspondent
Applied Membrane Technology, Inc.
11558 Encore Circle
Minnetonka,  MN  55343
Correspondent Contact STEPHEN P CONOVER
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received04/16/1986
Decision Date 05/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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